Status:
COMPLETED
Comparison of Atomoxetine Versus Placebo in Children and Adolescents With ADHD and Comorbid ODD in Germany
Lead Sponsor:
Eli Lilly and Company
Conditions:
Attention Deficit Hyperactivity Disorder
Oppositional Defiant Disorder
Eligibility:
All Genders
6-17 years
Phase:
PHASE4
Brief Summary
A three-arm, randomized, double-blind, placebo-controlled, Phase 4, multicenter study to compare the efficacy and safety of atomoxetine versus placebo in children and adolescents aged 6 through 17 yea...
Eligibility Criteria
Inclusion
- Male or female outpatients who are at least 6 years of age, and who will not have reached their 18th birthday
- Diagnosis of ADHD and presence of Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition (DSM-IV) criteria A through C for ODD (NOTE: diagnosis for conduct disorder not exclusionary)
- Normal intelligence
- Able to swallow capsules
Exclusion
- Weigh less than 20 kilogram (kg) or more than 90 kg at study entry
- Prior treatment with atomoxetine
- History of seizure disorder, suicidal risk, alcohol or drug abuse within the past 3 months
- History of severe allergies or multiple adverse drug reactions
- Cardiovascular disorders: hypertension, unexplained cardiac signs or symptoms, QT (measure of the time between the start of the Q wave and the end of the T wave in the heart's electrical cycle) prolongation , inherited cardiac disorders
Key Trial Info
Start Date :
November 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2009
Estimated Enrollment :
181 Patients enrolled
Trial Details
Trial ID
NCT00406354
Start Date
November 1 2006
End Date
January 1 2009
Last Update
February 26 2010
Active Locations (6)
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1
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Berlin, Germany, 10789
2
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Düsseldorf, Germany, 40215
3
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Fulda, Germany, 36037
4
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Hamburg, Germany, 22459